Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Comments Invited on European Commission Vision For IVDR EU Reference Laboratories

Executive Summary

Two long-awaited European Commission proposals have been published which shed light on how EU reference laboratories will operate under the IVD Regulation and likely timelines.

You may also be interested in...



Go-Ahead For Appointment Of European Union Reference Labs For IVDs

EURLs have been a critical missing element of the IVDR for assessing the higher-risk class D IVDs. Two new implementing regulations, on fees and tasks, bring them closer to designation.

Find Resources To Designate IVDR Notified Bodies, Commission Tells Member States

There is growing impetus at the highest EU levels towards ensuring the IVD Regulation is implemented as quickly and effectively as possible. Discussions at the Council of the EU have now added to this drive.

European Commission Publishes Draft Rules In Bid To Reclassify Non-Medical Active Products

The European Commission has launched an initiative to ensure products without a medical purpose that fall under the Medical Device Regulation are appropriately classified by risk, and subject to the same pre- and post-market requirements as comparable medical devices.

Topics

Latest News
See All
UsernamePublicRestriction

Register

MT144764

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel